Information to be provided as Instructions for Use with the medical device or IVD, or on the packaging of each unit or on the packaging of multiple devices or IVDs.
Instructions for the use of a medical device must be provided with the device.
However, instructions for the use of a medical device need not be provided with the device or may be abbreviated, if:
- the device is a Class A medical device and
- the device can be used safely for its intended purpose without instructions.
Instructions for the use of a medical device must include information mentioned in the following table that is applicable to the device.
|Item||Information to be supplied|
|1||Name and trade name of the medical device|
|2||Name and business address of the manufacturer; where practical, the approved indication for use of the medical device or IVD including in the case of a medical device, the intended user|
|3||The performance intended, where practical|
|4||Where the manufacturer has included clinical investigations as part of premarket conformity assessment to demonstrate conformity to the safety and performance criteria, a summary of the investigation, outcome data and clinical safety information, or a reference as to where such information may be accessed|
|5||Any residual risks, contraindications and any expected and foreseeable side effects, including information to be conveyed to the patient in this regard|
|6||Specifications that the user requires to use the device appropriately (e.g. if the device has a measuring function, the degree of accuracy claimed for it)|
|7||If the device contains, or incorporates, a medicinal substance and/or material of biological origin: identification of that substance or material, as appropriate|
|8||Details of any preparatory treatment or handling of the device before it is ready for use (e.g. sterilization, final assembly, calibration)|
|9||Any requirements for special facilities, or special training, or particular qualifications of the device user and/or third parties|
|10||The information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant:
details of the nature, and frequency, of preventative and regular maintenance, and of any preparatory cleaning or disinfection;
|11||Identification of any consumable components and how to replace them|
|12||Information on any necessary calibration to ensure that the device operates properly and safely during its intended life span; and
methods of eliminating the risks encountered by persons involved in installing, calibrating or servicing medical devices.
|13||An indication of any special storage and/or handling condition that applies|
|14||If the device is supplied sterile, instructions in the event of the sterile packaging being damaged before use;
If the device is supplied non-sterile with the intention that it is sterilized before use, the appropriate instructions for sterilization
|15||If the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of re-sterilization including information to identify when the device should no longer be reused (e.g. signs of material degradation or the maximum number of allowable reuses);|
|16||For devices intended for use together with other medical devices and/or general purpose equipment:
(i) information to identify such devices or equipment, in order to obtain a safe combination; and/or
(ii) information on any known restrictions to combinations of medical devices and equipment;
|17||If the device emits hazardous, or potentially hazardous levels of radiation for medical purposes:
(i) detailed information as to the nature, type and where appropriate, the intensity and distribution of the emitted radiation; and
(ii) the means of protecting the patient, user, or third party from unintended radiation during use of the device
|18||Information that allows the user and patient to be informed of warnings, precautions, measures to be taken and limitations of use regarding the medical device which information must cover, where appropriate
(i) warnings, precautions and measures to be taken in the event of malfunction of the medical device or changes in its performance that may affect safety;
(ii) warnings, precautions and measures to be taken in regard to the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature;
(iii) warnings ,precautions and limitations related to the scheduled substance or biological substance that is incorporated into the medical device as an integral part of the medical device; and
(iv) precautions and measures to be taken in regard to the risks of interference posed by the reasonably foreseeable presence of the medical device during specific diagnostic investigations, evaluations, therapeutic treatment or use (e.g. electromagnetic interference emitted by the medical device affecting other equipment)
(v) precautions related to materials incorporated into the medical device that are carcinogenic, mutagenic or toxic, or could result in sensitisation or allergic reaction of the patient or user.
|19||Warnings and precautions to be taken related to the disposal of the medical device, its accessories and the consumables used with it, if any. This information must cover, where appropriate-
(i) infection or microbial hazards (e.g. explants, needles or surgical equipment contaminated with potentially infectious substances of human origin);
(ii) environmental hazards (e.g. batteries or materials that emit potentially hazardous levels of radiation); and
(iii) physical hazards (e.g. from sharps)
|20||For medical devices intended for use by a lay-person, the circumstances when the user must consult with a healthcare professional;|
|21||The date of issue or latest revision of the instructions for use and, where appropriate, an identification number; and|
|22||Appropriate service and maintenance instructions for technical equipment and medical devices, where applicable.|